24960 Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 

Please Note: The contents of all 

submissions, regardless of format, will be 

available to the public upon request unless 

prohibited by law. 

The draft of this review will be posted 

on AHRQ’s EHC program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/join-the-email-list1/. 

The Key Questions 

Question 1 

What is the comparative effectiveness 

of the various liver-directed therapies in 

patients with hepatocellular carcinoma 

(HCC) who are not otherwise candidates 

for surgical resection or transplantation 

with no evidence of extrahepatic disease 

regarding survival and quality of life? 

Question 2 

What are the comparative harms of 

the various liver-directed therapies in 

patients with HCC who are not 

otherwise candidates for surgical 

resection or transplantation with no 

evidence of extrahepatic disease 

regarding adverse events? 

Question 3 

Are there differences in comparative 

effectiveness of various liver-directed 

therapies in patients with HCC who are 

not otherwise candidates for surgical 

resection or transplantation for specific 

patient and tumor characteristics, such 

as age, gender, disease etiology, and 

Child-Pugh score? 

Dated: April 19, 2012. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2012–10011 Filed 4–25–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day-12–0010] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

chapter 35). To request a copy of these 

requests, call (404) 639–7570 or send an 

email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–5806. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

The National Birth Defects Prevention 

Study (NBDPS)–(0920–0010, Expiration 

06/30/2012)—Extension—National 

Center on Birth Defects and 

Developmental Disabilities (NCBDDD), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

CDC has been monitoring the 

occurrence of serious birth defects and 

genetic diseases in Atlanta since 1967 

through the Metropolitan Atlanta 

Congenital Defects Program (MACDP). 

The MACDP is a population-based 

surveillance system for birth defects in 

the 5 counties of Metropolitan Atlanta. 

Its primary purpose is to describe the 

spatial and temporal patterns of birth 

defects occurrence and serves as an 

early warning system for new 

teratogens. In 1997, the Birth Defects 

Risk Factor Surveillance (BDRFS) study, 

a case-control study of risk factors for 

selected birth defects, became the 

National Birth Defects Prevention Study 

(NBDPS). The major components of the 

study did not change. 

The NBDPS is a case-control study of 

major birth defects that includes cases 

identified from existing birth defect 

surveillance registries in nine states, 

including metropolitan Atlanta. Control 

infants are randomly selected from birth 

certificates or birth hospital records. 

Mothers of case and control infants are 

interviewed using a computer-assisted 

telephone interview. The interview 

takes approximately one hour. A 

maximum of thirty-six hundred 

interviews are planned, 2,700 cases and 

900 controls, resulting in a maximum 

interview burden of approximately 

3,600 hours for all Centers. 

Parents are also asked to collect cheek 

cells from themselves and their infants 

for DNA testing. The collection of cheek 

cells by the mother, father, and infant is 

estimated to take about 10 minutes per 

person. Each person will be asked to rub 

1 brush inside the left cheek and 1 

brush inside the right cheek for a total 

of 2 brushes per person. Collection of 

the cheek cells takes approximately 

1–2 minutes, but the estimate of burden 

is 10 minutes to account for reading and 

understanding the consent form and 

specimen collection instructions and 

mailing back the completed kits. The 

anticipated maximum burden for 

collection of the cheek cells is 1,800 

hours for all Centers. 

Information gathered from both the 

interviews and the DNA specimens will 

be used to study independent genetic 

and environmental factors as well as 

gene-environment interactions for a 

broad range of carefully classified birth 

defects. 

This request is submitted to obtain 

OMB clearance for three additional 

years. 

There are no costs to the respondents 

other than their time. The total 

estimated annualized burden is 5,400 

hours. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Mothers ................................................ NBDPS mother questionnaire ................................... 3,600 1 1 

Mothers, fathers, infants ...................... Cheek Cell Specimen Collection .............................. 10,800 1 10/60 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices 24961 

Kimberly S. Lane, 

Deputy Director, Office of Science Integrity, 

Office of the Associate Director for Science, 

Office of the Director, Centers for Disease 

Control and Prevention. 

[FR Doc. 2012–10035 Filed 4–25–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0902] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prescription Drug 

Product Labeling: Medication Guide 

Requirements 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by May 29, 

2012. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0393. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Juanmanuel Vilela, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–7651, 

juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Prescription Drug Product Labeling; 

Medication Guide Requirements (OMB 

Control Number 0910–0393)—Extension 

FDA regulations require the 

distribution of patient labeling, called 

Medication Guides, for certain 

prescription human drug and biological 

products used primarily on an 

outpatient basis that pose a serious and 

significant public health concern 

requiring distribution of FDA-approved 

patient medication information. These 

Medication Guides inform patients 

about the most important information 

they should know about these products 

in order to use them safely and 

effectively. Included is information such 

as the drug’s approved uses, 

contraindications, adverse drug 

reactions, and cautions for specific 

populations, with a focus on why the 

particular product requires a Medication 

Guide. These regulations are intended to 

improve the public health by providing 

information necessary for patients to use 

certain medication safely and 

effectively. 

The regulations contain the following 

reporting requirements that are subject 

to the PRA. The estimates for the burden 

hours imposed by the following 

regulations are listed in table 1 of this 

document: 

• 21 CFR 208.20—Applicants must 

submit draft Medication Guides for FDA 

approval according to the prescribed 

content and format. 

• 21 CFR 208.24(e)—Each authorized 

dispenser of a prescription drug product 

for which a Medication Guide is 

required, when dispensing the product 

to a patient or to a patient’s agent, must 

provide a Medication Guide directly to 

each patient unless an exemption 

applies under 21 CFR 208.26. 

• 21 CFR 208.26 (a)—Requests may 

be submitted for exemption or deferral 

from particular Medication Guide 

content or format requirements. 

• 21 CFR 314.70(b)(3)(ii) and 21 CFR 

601.12(f)—Application holders must 

submit changes to Medication Guides to 

FDA for prior approval as supplements 

to their applications. 

In the Federal Register of December 

21, 2011 (76 FR 79194), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received the following 

comments: 

(Comment 1) One comment states that 

FDA’s hourly burden estimate of 3 

minutes per Medication Guide for 

pharmacists to comply with the 

requirements is miscalculated, although 

more in line with current practices 

versus previous FDA estimates. 

(Response) Because the comment did 

not indicate if the miscalculation was 

over-or under-estimated or provide 

alternative burden estimates for 

pharmacy time associated with 

distribution of a Medication Guide, we 

continue to use 3 minutes as the 

estimated burden for pharmacists to 

distribute Medication Guides to 

patients. 

(Comment 2) One comment said that 

there are distributor costs to comply 

with the Medication Guide 

requirements and FDA’s estimate omits 

§ 208.24(c), which provides that ‘‘Each 

distributor or packer that receives 

Medication Guides, or the means to 

produce Medication Guides, from a 

manufacturer under paragraph (b) of 

this section shall provide those 

Medication Guides, or the means to 

produce Medication Guides, to each 

authorized dispenser to whom it ships 

a container of drug product.’’ The 

comment states that the December 21, 

2011, notice of proposed information 

collection (76 FR 79194) does not 

include an estimate for the reporting 

requirements of § 208.24(c) and that the 

requirement should be included in 

FDA’s assessment. 

(Response) FDA has re-evaluated 

§ 208.24(c) with regards to information 

collection burden on distributors and 

packers and determined that § 208.24(c) 

does not contain an additional 

collection of information subject to the 

reporting requirements of the PRA. A 

‘‘collection of information’’ includes an 

Agency request or requirement that 

members of the public submit reports, 

keep records, or provide information to 

third parties or the public by or for an 

Agency. Therefore, the manufacturer is 

responsible for providing information to 

third parties (§ 208.24(a)), i.e., 

Medication Guides, and the distributor 

or packer distributes the Medication 

Guides with the shipment of drugs to 

the dispensers. Thus, § 208.24(c) is not 

subject to the reporting requirements of 

the PRA. 

(Comment 3) One comment says that 

FDA should reassess the need to 

provide Medication Guides with each 

prescription refill and states there are 

situations where it is not necessary due 

to certain circumstances. The comment 

states that Medication Guides should be 

a tool to enhance the level of care to 

consumers, rather than a hindrance to 

pharmacists in their ability to provide 

quality patient care. 

(Response) FDA agrees and directs the 

comment to the guidance made 

available to the public entitled 

‘‘Medication Guides—Distribution 

Requirements and Inclusion in Risk 

Evaluation and Mitigation Strategies 

(REMS).’’ In this guidance, FDA 

articulates the circumstances under 

which FDA intends to exercise 

enforcement discretion regarding the 

requirement to provide Medication 

Guides in certain settings. 


tkelley on DSK3SPTVN1PROD with NOTICES